title: Denosumab compared with ibandronate in postmenopausal women previously treated with bisphosphonate therapy: a randomized open-label trial.
abstract: OBJECTIVE
  To compare the efficacy and safety of denosumab to ibandronate in postmenopausal women with low bone mineral density (BMD) previously treated with a bisphosphonate.
  
  
  METHODS
  In a randomized, open-label study, postmenopausal women received 60 mg denosumab subcutaneously every 6 months (n=417) or 150 mg ibandronate orally every month (n=416) for 12 months. End points included percentage change from baseline in total hip, femoral neck, and lumbar spine BMD at month 12 and percentage change from baseline in serum C-telopeptide at months 1 and 6 in a substudy.
  
  
  RESULTS
  At month 12, significantly greater BMD gains from baseline were observed with denosumab compared with ibandronate at the total hip (2.3% compared with 1.1%), femoral neck (1.7% compared with 0.7%), and lumbar spine (4.1% compared with 2.0%; treatment difference P<.001 at all sites). At month 1, median change in serum C-telopeptide from baseline was -81.1% with denosumab and -35.0% with ibandronate (P<.001); the treatment difference remained significant at month 6 (P<.001). Adverse events occurred in 245 (59.6%) denosumab-treated women and 230 (56.1%) ibandronate-treated women (P=.635). The incidence of serious adverse events was 9.5% for denosumab-treated women and 5.4% for ibandronate-treated women (P=.046). No clustering of events in any organ system accounted for the preponderance of these reports. The incidence rates of serious adverse events involving infection and malignancy were similar between treatment groups.
  
  
  CONCLUSIONS
  In postmenopausal women previously treated with a bisphosphonate and low BMD, denosumab treatment resulted in greater BMD increases than ibandronate at all measured sites. No new safety risks with denosumab treatment were identified.
authors.affiliation: United Osteoporosis Centers, Gainesville, Georgia; Medical College Jagiellonian University, Krakow, Poland; Michigan Bone and Mineral Clinic, Detroit, Michigan; the Clinical Research Center of North Texas, Denton, Texas; the University of Wisconsin-Madison Osteoporosis Clinical Center and Research Program, Madison, Wisconsin; the Palacios Institute of Woman's Health, Madrid, Spain; OB-GYN Associates of Mid Florida, PA, Leesburg, Florida; Amgen Inc, Thousand Oaks, California; Amgen Ltd, Cambridge, United Kingdom; Ovatech Solutions Ltd, London, United Kingdom; The Bethesda Health Research Center, Bethesda, Maryland; and Institut National de la Santé et de la Recherche Médicale (INSERM) U658, CHR d'Orléans, Orléans, France.
authors.forename: Chris
authors.initials: C
authors.lastname: Recknor
authors.forename: Edward
authors.initials: E
authors.lastname: Czerwinski
authors.forename: Henry G
authors.initials: HG
authors.lastname: Bone
authors.forename: Sydney L
authors.initials: SL
authors.lastname: Bonnick
authors.forename: Neil
authors.initials: N
authors.lastname: Binkley
authors.forename: Santiago
authors.initials: S
authors.lastname: Palacios
authors.forename: Alfred
authors.initials: A
authors.lastname: Moffett
authors.forename: Suresh
authors.initials: S
authors.lastname: Siddhanti
authors.forename: Irene
authors.initials: I
authors.lastname: Ferreira
authors.forename: Prayashi
authors.initials: P
authors.lastname: Ghelani
authors.forename: Rachel B
authors.initials: RB
authors.lastname: Wagman
authors.forename: Jesse W
authors.initials: JW
authors.lastname: Hall
authors.forename: Michael A
authors.initials: MA
authors.lastname: Bolognese
authors.forename: Claude-Laurent
authors.initials: CL
authors.lastname: Benhamou
mesh_terms: D000368:Aged; D061067:Antibodies, Monoclonal, Humanized / Q000494:pharmacology / Q000627:therapeutic use*; D015519:Bone Density / Q000187:drug effects*; D050071:Bone Density Conservation Agents / Q000494:pharmacology / Q000627:therapeutic use*; D000069448:Denosumab; D004164:Diphosphonates / Q000494:pharmacology / Q000627:therapeutic use*; D005260:Female; D050723:Fractures, Bone / Q000517:prevention & control*; D006801:Humans; D000077557:Ibandronic Acid; D008875:Middle Aged; D010024:Osteoporosis / Q000188:drug therapy*; D053245:RANK Ligand / Q000037:antagonists & inhibitors
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D050071:Bone Density Conservation Agents; D004164:Diphosphonates; D053245:RANK Ligand; D000069448:Denosumab; D000077557:Ibandronic Acid